European Medical Device Regulations

RGA 6222 4 Quarter Hours
Course Level CPS - Graduate
Description Covers European Commission directives and guidance documents; European Agency for the Evaluation of Medicinal Products, medical device guidance documents, and notified body guidelines and recommendations; Global Harmonization Task Force final reports; and mutual recognition agreements. Topics include biological and biotechnological products, CE marking, conformity assessment and notified bodies, the Global Harmonization Task Force, clinical trials, and standardization.


Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.


Course Sections

Section 01
CRN 20603
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Raina Olexa
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

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